Initiation of Investigator-Initiated Clinical Trial Using Astatine for Treatment-Resistant Prostate Cancer
– Aiming for the World’s First Practical Astatine-Based Therapy for Prostate Cancer –

Alpha Fusion Inc. (CEO: Tadashi Fujioka, Head Office: Kita-ku, Osaka; hereafter “Alpha Fusion”) is pleased to announce that a new investigator-initiated clinical trial targeting treatment-resistant prostate cancer will commence in June 2024 at the Department of Nuclear Medicine, Osaka University Hospital. The study is led by Dr. Tadashi Watanabe, Lecturer at the Department of Radiology, Osaka University Graduate School of Medicine, in collaboration with Alpha Fusion.

The investigational drug, [At-211]PSMA-5, developed by Dr. Watanabe’s research team, targets Prostate-Specific Membrane Antigen (PSMA), a protein expressed in prostate cancer cells. In preclinical studies using prostate cancer mouse models, a single dose of [At-211]PSMA-5 demonstrated sustained tumor regression over an extended period, highlighting its potential as a highly promising therapeutic candidate.

This clinical trial was selected for funding by the Japan Agency for Medical Research and Development (AMED) under the Translational Research Program (Seeds F). The project, titled “Implementation of an Investigator-Initiated Clinical Trial for a Novel Alpha-Emitter Therapeutic Targeting PSMA”, recognizes the drug’s potential, its pathway to clinical application, and the collaborative framework between Osaka University and Alpha Fusion. Alpha Fusion is committed to supporting the development of [At-211]PSMA-5 toward becoming the world’s first astatine-based prostate cancer therapy.

The trial will be a Phase I study evaluating the safety, tolerability, pharmacokinetics, and efficacy of [At-211]PSMA-5 in patients with castration-resistant prostate cancer who are unable to continue standard therapies. This will mark the first time the drug is administered to humans. The trial follows a standard dose-escalation design, starting from a low dose and gradually increasing.

Trial Information

• Title: Phase I Investigator-Initiated Clinical Trial of a Novel Alpha Radiopharmaceutical Therapy for Castration-Resistant Prostate Cancer
• Target Population: Patients with castration-resistant prostate cancer for whom standard treatments are no longer feasible
• Investigational Drug: PSW-1025 (compound name: [At-211]PSMA-5)
• Study Period: June 2024 – March 2027 (planned)
• Planned Enrollment: 15 patients
• Principal Investigator: Dr. Tadashi Watanabe (Department of Nuclear Medicine, Osaka University Hospital)

For further details, please refer to the joint press release by Osaka University, RIKEN, and Alpha Fusion Inc.:
https://resou.osaka-u.ac.jp/ja/research/2024/20240527_1

（Read More in Japanese）